FDA clears quick and inexpensive home COVID-19 tests


the details on COVID-19 home testing are changing and in ways that could have a major impact on our ability to cope with the pandemic. FDA has now cleared several rapid tests for over-the-counter use (that is, without a prescription or prior medical approval) to screen for people who do not have symptoms of the disease. According to the FDA, “the addition of OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable.”

The first tests authorized for home screening are the Quidel QuickVue and Abbott BinaxNOW COVID-19 Antigen Self Test. They had previously been approved to test people who already have symptoms, but are now allowed to perform routine screening on a regular basis for people who do not have any symptoms. They can also be used to get negative results before people return to school or work and be in the company of other people.

The idea is that by enabling large-scale rapid testing that includes people who do not show symptoms of infection, we can detect cases of COVID-19 earlier and slow its spread. Everything people need for the test comes in the box, and they can be used on children as young as two years old. Abbott says his BinaxNOW test can return results in 15 minutes and will be available online or off the shelf at major retailers in the coming weeks.

Other tests that gain approval include the Abbott BinaxNOW COVID-19 Ag Card 2 test which is available for use in the home with the help of a telehealth supervisor or at a point of care, but no longer requires no doctor’s prescription to be administered. The BD Veritor System for the Rapid Detection of SARS-CoV-2 is also approved for use in healthcare settings.

Separately, the CDC and the National Institute of Health are try a rapid home testing initiative in two communities where thousands of residents will receive kits that they can use on themselves three times a week for a month. They are trying to find out if frequent self-tests can help reduce the spread of COVID-19, and see it as a way to collect important data in North Carolina and Tennessee. NIH Director Francis S. Collins said in a press release “This testing initiative is the first of this scale to attempt to make free, rapid, and self-administered tests available throughout the community to determine their effectiveness in our country’s overall response to the COVID-19 pandemic.”



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